Advice

NICE has developed a medtech innovation briefing (MIB) on ClearWay RX for drug delivery to coronary artery thrombotic lesions.

The ClearWay RX is a rapid exchange perfusion catheter for localised delivery of diagnostic or therapeutic agents, including drugs such as abciximab to dissolve blood clots in coronary arteries. The relevant evidence for this indication is very limited in quantity and comes from 2 small randomised controlled trials (1 available only as a conference presentation) which were inadequately or not powered to detect important differences in clinical outcomes. The published COCTAIL trial showed no significant difference in the primary outcome (thrombus score) but improvement in some outcomes for patients having abciximab using ClearWay RX compared with guide catheter or intravenous administration. These included the extent of stenosis, thrombolysis in myocardial infarction frame count, procedure-related myocardial infarctions and major adverse coronary events at 1 year. The list price of a single ClearWay RX unit is £600 excluding VAT.

MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.

Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.

MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.

MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.